Milestone Pharmaceuticals has reported positive topline findings from the Phase III RAPID clinical trial of its lead investigational product, etripamil, in paroxysmal supraventricular tachycardia (PSVT) patients.
The randomised, multicentre, double-blind, placebo-controlled trial enrolled 706 subjects across clinical sites in Europe and North America.
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Subjects were categorised into a 1:1 ratio to receive a nasal spray of either etripamil or placebo without medical monitoring.
According to the findings, the trial met its primary endpoint with subjects in the etripamil arm showing a highly statistically significant and clinically meaningful difference in time to PSVT conversion versus placebo.
As per Kaplan Meier analysis, 64.3% of the subjects who self-administered etripamil converted to sinus rhythm within 30 minutes as against 31.2% on placebo.
For subjects in the etripamil arm, the median time to conversion was also three times quicker compared to those who received a placebo.
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By GlobalDataThe safety and tolerability data from the trial continue to back the possible self-usage of etripamil, with results in line with those seen in previous studies.
A new calcium channel blocker, etripamil is created to be a rapid-response treatment for episodic cardiovascular conditions.
Apart from this trial, a Phase II proof-of-concept trial is progressing in individuals with atrial fibrillation with a rapid ventricular rate (AFib-RVR).
The company intends to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) mid-next year.
Milestone Pharmaceuticals president and CEO Joseph Oliveto said: “We believe that etripamil, if approved, has the potential to empower patients to take control of their condition as well as provide value to the healthcare system, in part by reducing visits to the Emergency Department.
“We look forward to working with the US Food and Drug Administration (FDA) to make available what we believe is the first of its kind, self-administered therapy.”
